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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR VEMURAFENIB

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Clinical Trials for Vemurafenib

Trial ID Title Status Sponsor Phase Summary
NCT00949702 A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma Unknown status Hoffmann-La Roche Phase 2 This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is <100 patients.
NCT01006980 A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3) Completed Hoffmann-La Roche Phase 3 This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.
NCT01271803 A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma Active, not recruiting Hoffmann-La Roche Phase 1 This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.
NCT01286753 A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation Completed Hoffmann-La Roche Phase 2 This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.
NCT01378975 A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases Completed Hoffmann-La Roche Phase 2 This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.
NCT01400451 Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) Terminated Roche-Genentech Phase 1 Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.
NCT01400451 Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) Terminated Bristol-Myers Squibb Phase 1 Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Vemurafenib

Condition Name

Condition Name for Vemurafenib
Intervention Trials
Melanoma 33
Malignant Melanoma 17
Metastatic Melanoma 8
Malignant Melanoma, Neoplasms 6
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Condition MeSH

Condition MeSH for Vemurafenib
Intervention Trials
Melanoma 84
Neoplasm Metastasis 10
Neoplasms 9
Thyroid Neoplasms 5
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Clinical Trial Locations for Vemurafenib

Trials by Country

Trials by Country for Vemurafenib
Location Trials
United States 397
Italy 81
Spain 49
Australia 41
Germany 38
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Trials by US State

Trials by US State for Vemurafenib
Location Trials
Texas 29
California 28
New York 27
Massachusetts 22
Tennessee 20
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Clinical Trial Progress for Vemurafenib

Clinical Trial Phase

Clinical Trial Phase for Vemurafenib
Clinical Trial Phase Trials
Phase 4 4
Phase 3 7
Phase 2 60
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Clinical Trial Status

Clinical Trial Status for Vemurafenib
Clinical Trial Phase Trials
Recruiting 52
Active, not recruiting 20
Completed 15
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Clinical Trial Sponsors for Vemurafenib

Sponsor Name

Sponsor Name for Vemurafenib
Sponsor Trials
Hoffmann-La Roche 29
Genentech, Inc. 23
National Cancer Institute (NCI) 9
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Sponsor Type

Sponsor Type for Vemurafenib
Sponsor Trials
Other 107
Industry 75
NIH 10
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Daiichi Sankyo
Healthtrust
Covington
US Army
Harvard Business School
Chinese Patent Office
Colorcon
US Department of Justice

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